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4965 Post-approval Study - NCT01076348-(Clinical Trial 563880)



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City:  Milwaukee
State:  
WI
Zip Code:
Conditions: Arrhythmia - Heart Failure
Purpose: Safety and effectiveness will be summarized for the model 4965 lead.
Study summary: As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who are > 19 years old will be followed for one-year post-implant.
Criteria: Inclusion Criteria: - Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board - Availability of implant, follow-up, and product-related event data - Implanted with a Model 4965 Capsure Epi Lead - 19 years of age or older Exclusion Criteria: - Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant - Subjects who are, or will be inaccessible for follow-up at a 4965 Post-approval study center - Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded - Subjects with exclusion criteria required by local law
Study is available at:
Milwaukee, WI
United States

Primary Contact:
4965 Clinical Trial Leader
Email: medtronicCRMtrials@medtronic.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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